Clinical trial · Interventional
Observation or Radiation Therapy and/or Chemotherapy and Second Surgery in Treating Children Who Have Undergone Surgery for Ependymoma
A Phase II Trial of Conformal Radiation Therapy for Pediatric Patients With Localized Ependymoma, Chemotherapy Prior to Second Surgery for Incompletely Resected Ependymoma and Observation for Completely Resected, Differentiated, Supratentorial Ependymoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy before surgery may shrink the tumor so that it can be removed during surgery. PURPOSE: Phase II trial to determine the effectiveness of specialized radiation therapy either alone or after chemotherapy and second surgery in treating children who have undergone surgery for localized ependymoma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Tumor | Brain Neoplasm | ALIAS | 0.90 |
| Central Nervous System Tumor | Central Nervous System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| Mesna | Drug | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
| vincristine sulfate | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- GTR1 Differentiated Histology Supratentorial (Group 1)
- description
- Patients undergo observation.
- type
- EXPERIMENTAL
- label
- Radiation (Group 2)
- description
- Supratentorial Anaplastic Ependymoma (GTR1, GTR2, NTR) and Anaplastic or Differentiated Infratentorial Ependymoma (GTR1, GTR2, NTR) and Supratentorial Differentiated Ependymoma(GTR2, NTR). Patients undergo conformal radiation therapy to the brain once daily 5 days a week for 6-6½ weeks.
- interventionNames
- Radiation: radiation therapy
- type
- EXPERIMENTAL
- label
- Sub-Total Resection Any Histology or Location (STR) (Group 3)
- description
- Patients receive an initial course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously or IV beginning on day 3 and continuing until blood counts recover. Patients then receive a second course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and oral etoposide on days 1-21. After completion of chemotherapy, patients are evaluated for second therapeutic conventional surgery. Patients who have unresectable disease undergo conformal radiation therapy. Patients who have resectable disease undergo second surgery followed by conformal radiotherapy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 21 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed intracranial ependymoma * Differentiated ependymoma or anaplastic ependymoma * No primary spinal cord ependymoma, myxopapillary ependymoma, subependymoma, ependymoblastoma, or mixed glioma * No evidence of noncontiguous spread beyond primary site * Initial surgical resection within the past 56 days PATIENT CHARACTERISTICS: Age: * 1 to 21 Performance status: * No restrictions Life expectancy: * At least 2 months Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * Able to undergo MRI * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy Endocrine therapy: * Prior or concurrent corticosteroids allowed Radiotherapy: * No prior radiotherapy Surgery: * See Disease Characteristics * More than 1 prior surgery allowed Other: * No other prior treatment for ependymoma
References
Publications (0)
Data not yet available